Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT03807102
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-29
First Post:
2019-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trial of Tumor Vaccine Used for Adjuvant Therapy in Post Radical Operation Patients With Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019496', 'term': 'Cancer Vaccines'}], 'ancestors': [{'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-25', 'studyFirstSubmitDate': '2019-01-04', 'studyFirstSubmitQcDate': '2019-01-12', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free Survival (DFS)', 'timeFrame': 'Approximately 2 years', 'description': 'The time that participants stay free of cancer after surgery following administration of tumor vaccine'}, {'measure': 'Adverse Events (AEs)', 'timeFrame': '30 days from first study vaccine administration', 'description': 'Number of participants experiencing clinical and laboratory adverse events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung Cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Tumor vaccines may make the body build an immune response to kill tumor cells. This research study is evaluating a new type of tumor vaccine termed as "Neoantigen Tumor Vaccine". The purpose of this phase I/II trial study is to assess the safety and effectiveness of neoantigentumor vaccine in post radical operation patients with stage IIIA lung cancer.', 'detailedDescription': 'Outline: After successful vaccine manufacturing, patients receive neoantigen tumor vaccine hypodermically (5 injections for each 3 days and then 1 injection for each 3 months till recurrence or up to 2 years). Treatment continues in the absence of disease recurrence and metastasis or unacceptable toxicity.\n\nPatients are followed for 2 years or up to the absence of disease recurrence and metastasis.\n\nProjected accrual: A total of 30 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 to 70 years, Male or Female\n* Histological or cytologically diagnosis of lung adenocarcinoma\n* After surgical treatment (lobectomy and systematic lymph node dissection)\n* Pathological stage IIIA (According to the IASLC Lung Cancer Staging (eight Edition))\n* Postoperative standard treatment (platinum-based double-drug adjuvant treatment with or without chemotherapy) or no adjuvant treatment\n* Have potential dynamic tumor biomarkers\n* Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure, agree to participate in long-term follow-up for up to 3 years\n\nExclusion Criteria:\n\n* Age \\< 18 or\\< 70 years\n* Lung squamous cell carcinoma, small cell lung cancer, large cell lung cancer\n* Without surgical treatment\n* Pathological stage I、II、IIIB、IIIC or IV (According to the IASLC Lung Cancer Staging (eight Edition))\n* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study vaccine\n* Drug or alcohol abusers\n* Pregnant or breast-feeding patients\n* History of immunodeficiency disease or autoimmune disease\n* Patients with chronic disease which is undergoing immune reagents or hormone therapy\n* Concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy\n* Lack of availability of a patient for immunological and clinical follow-up'}, 'identificationModule': {'nctId': 'NCT03807102', 'acronym': 'TVATLC01', 'briefTitle': 'Trial of Tumor Vaccine Used for Adjuvant Therapy in Post Radical Operation Patients With Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hunan Province Tumor Hospital'}, 'officialTitle': 'Phase I/II Trial of Tumor Vaccine in Post Radical Operation Patients With Lung Cancer', 'orgStudyIdInfo': {'id': 'TVATLC01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tumor Vaccine', 'description': 'Injection of NeoAntigen Tumor Vaccine', 'interventionNames': ['Biological: Tumor Vaccine']}], 'interventions': [{'name': 'Tumor Vaccine', 'type': 'BIOLOGICAL', 'description': 'NeoAntigen Tumor Vaccine (5 injections for each 3 days and then 1 injection for each 3 months till recurrence or up to 2 years).', 'armGroupLabels': ['Tumor Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Hunan Provincal Tumor Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Nong Yang, MD', 'role': 'CONTACT', 'email': 'yangnong0217@163.com', 'phone': '+86 731 89762323'}], 'overallOfficials': [{'name': 'Wenxiang Wang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hunan Provincal Tumor Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yongchang Zhang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Houchao Biotechnology Co., Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, pHD, Director of Thoracic Surgery Department II', 'investigatorFullName': 'Yongchang Zhang', 'investigatorAffiliation': 'Hunan Province Tumor Hospital'}}}}